Drug Enforcement D-0509-2023

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Status

Ongoing

Classification

Class II

Report Date

April 12, 2023

Termination Date

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Product Information

Product description
Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
Product quantity
9 bottles
Reason for recall
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Direct Rx
Address
94 Worldwide Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0509-2023
Event ID
92054
Recall initiation date
March 22, 2023
Center classification date
April 6, 2023
Code info
Lots: 03FE2319 Exp. 2/28/25, 13MY2217 Exp. 5/31/23
More code info
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